Table 3.
Treatment failure (primary endpoint) overall and in predefined subgroups
| Gatifloxacin (events/n [%]) | Ceftriaxone (events/n [%]) | Hazard ratio of time to failure (95% CI); p value | Heterogeneity test (pinteraction value) | ||
|---|---|---|---|---|---|
| All patients (modified intention-to-treat population) | 18/120 (15%) | 19/119 (16%) | 1·04 (0·55−1·98); p=0·91 | ||
| Culture-negative or culture-positive populations | <0·0001 | ||||
| Culture negative | 2/58 (3%) | 15/65 (23%) | 7·50 (1·71−32·80); p=0·01 | ||
| Culture positive | 16/62 (26%) | 4/54 (7%) | 0·24 (0·08−0·73); p=0·01 | ||
| Pathogen (culture-confirmed population) | 0·25 | ||||
| Salmonella Paratyphi A | 1/19 (5%) | 1/16 (6%) | 1·13 (0·07−18·02); p=0·93 | ||
| Salmonella Typhi | 15/43 (35%) | 3/38 (8%) | 0·18 (0·05−0·62); p=0·01 | ||
| Age (modified intention-to-treat population) | 0·25 | ||||
| <16 years | 6/32 (19%) | 4/36 (11%) | 0·57 (0·16−2·00); p=0·38 | ||
| ≥16 years | 12/88 (14%) | 15/83 (18%) | 1·31 (0·61−2·80); p=0·48 | ||
| Age (culture-confirmed population) | 0·76 | ||||
| <16 years | 6/21 (29%) | 1/16 (6%) | 0·19 (0·02−1·62); p=0·13 | ||
| ≥16 years | 10/41 (24%) | 3/38 (8%) | 0·27 (0·07−0·98); p=0·047 | ||
| Sex (modified intention-to-treat population) | 0·52 | ||||
| Female | 3/21 (14%) | 4/38 (11%) | 0·69 (0·15−3·07); p=0·62 | ||
| Male | 15/99 (15%) | 15/81 (19%) | 1·21 (0·59−2·47); p=0·61 | ||
| Sex (culture-confirmed population) | 0·08 | ||||
| Female | 3/11 (27%) | 0/17 | 0 (0–∞); p=1·00 | ||
| Male | 13/51 (25%) | 4/37 (11%) | 0·37 (0·12−1·15); p=0·09 | ||
| Recruitment date (modified intention-to-treat population) | 0·15 | ||||
| Before April 1, 2013 | 7/62 (11%) | 11/59 (19%) | 1·69 (0·66−4·36); p=0·28 | ||
| April 1, 2013, or later | 11/58 (19%) | 8/60 (13%) | 0·65 (0·26−1·61); p=0·35 | ||
| Recruitment date (culture-confirmed population) | 0·70 | ||||
| Before April 1, 2013 | 6/33 (18%) | 1/28 (4%) | 0·18 (0·02−1·46); p=0·11 | ||
| April 1, 2013, or later | 10/29 (34%) | 3/26 (12%) | 0·28 (0·08−1·00); p=0·05 | ||
| MIC against ciprofloxacin (culture-confirmed population) | 0·15 | ||||
| <0·12 μg/mL | 0/4 | 1/3 (33%) | ∞ (0–∞); p=1·00 | ||
| 0·12−2·00 μg/mL | 8/45 (18%) | 2/46 (4%) | 0·22 (0·05−1·05); p=0·06 | ||
| >2·00 μg/mL* | 8/10 (80%) | 1/4 (25%) | 0·17 (0·02−1·38); p=0·10 | ||
| MIC against gatifloxacin (culture-confirmed population) | 0·58 | ||||
| ≤1 μg/mL | 8/49 (16%) | 3/49 (6%) | 0·34 (0·09−1·28); p=0·11 | ||
| >1 μg/mL | 8/10 (80%) | 1/4 (25%) | 0·17 (0·02−1·38); p=0·10 | ||
MIC=minimum inhibitory concentration.
*
Among the 14 strains, two had a ciprofloxacin MIC of 24 μg/mL and 12 had a ciprofloxacin MIC>32 μg/mL.